Kiora Pharmaceuticals, Inc. · NASDAQ:KPRX
Kiora Pharmaceuticals — EyeGate Pharmaceuticals — Investor Presentation (September 2021)
30 slides from Kiora Pharmaceuticals's investor presentation, Sep 14, 2021
Slide 1: EyeGate Pharmaceuticals (NASDAQ: EYEG) Sept 2021
EyeGate Pharmaceuticals (NASDAQ: EYEG) Sept 2021
Slide 2: Forward Looking Statements
2 Forward Looking Statements Some of the statements are “forward - looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995 . These “forward - looking” statements include statements relating to, among other things, the commercialization effo
Slide 3: Corporate Overview
3 • Pipeline in ophthalmology transformed by Panoptes acquisition and Bayon pending acquisition • PP - 001 is a best - in - class DHODH inhibitor • B - 203 is a small molecule capable of conferring light sensitivity to degenerating retinas* Corporate Overview • PP - 001 Phase 2 PoC trial in Dry Eye
Slide 4: Corporate Overview
4 Corporate Overview PP - 001: 4 th gen small - molecule Dihydroorotate Dehydrogenase (DHODH) inhibitor – Validated immunomodulatory class, approved for RA (Sanofi - Arava) and MS (Sanofi - Aubagio) – Best - in - class with picomolar potency with no off - target side effects of prior generations Eye
Slide 5: Pipeline - Unique platforms addressing ophthalmic diseases
5 Pipeline - Unique platforms addressing ophthalmic diseases Category Product Formulation Indication Development Stage Anticipated Near - Term Milestones Pre - clin Phase 1 Phase 2 Phase 3 Anterior Segment Ocular Surface Disease PP - 001 eye drop Moderate - Severe DED • Data from PoC Ph2 Trial in Q4
Slide 6: PP-001 DHODH Inhibitor
PP - 001 DHODH Inhibitor
Slide 7: Dry Eye: Opportunity
7 Dry Eye: Opportunity • A multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film – Inflammation is the common denominator of pathogenesis • Significantly affects the quality of life – Chronicity, pain and irritation, blindness in severe form • Tens of m
Slide 8: Why Target Dry Eye Disease with PP-001
8 Why Target Dry Eye Disease with PP - 001 PP - 001 acts upstream to inhibit proliferation of T helper cells (Th1 and Th17) in lymph node Dry Eye Disease is T - Cell Mediated Perez et al., THE OCULAR SURFACE 2016, VOL. 14 NO. 2
Slide 9: PP-001: an Inhibitor of Dihydroorotate Dehydrogenase (DHODH)
9 DHODH is an essential mitochondrial enzyme in the pyrimidine pathway for activated / abnormally proliferating cells – targeting DHODH ideal for disease specific therapeutic intervention PP - 001: an Inhibitor of Dihydroorotate Dehydrogenase (DHODH) • Inhibition of activated lymphocyte proliferatio
Slide 10: DHODH Inhibitors – Validated Drug Class for Autoimmune Diseases
10 DHODH Inhibitors – Validated Drug Class for Autoimmune Diseases 1. Arava (leflunomide) approved in 1998 for rheumatoid arthritis 2. Aubagio (teriflunomide) approved in 2012 for multiple sclerosis • Teriflunomide is the active metabolite of leflunomide Sanofi: 2 versions of once - daily oral table
Slide 11: PP-001: A First-in-Class Drug for Ophthalmic Chronic Inflammation
11 PP - 001: A First - in - Class Drug for Ophthalmic Chronic Inflammation • Clinical development efforts focused in ophthalmology – High medical need for novel new immunomodulators/anti - inflammatories – Multiple diseases in the anterior and posterior regions of the eye offering substantial market
Slide 12: PP-001: Preclinical In Vivo Proof-of-Concept
12 PP - 001: Preclinical In Vivo Proof - of - Concept Scopolamine patch applied for 20 days and placed in a controlled environment chamber – 16 eyes per group were treated with 10µl QID for 20 days Untreated Vehicle Restasis PP - 001 PP - 001 Treated Vehicle Control
Slide 13: PP-001: Phase 1/2a Dry Eye Trial – Fully Enrolled
13 PP - 001: Phase 1/2a Dry Eye Trial – Fully Enrolled Enrolled healthy volunteer s (N=24, 8/cohort) Day 28 Final Follow - up Cohort 1: PP - 001 (0.05%) Cohort 2: PP - 001 (0.15%) Dose Escalation Day 1 Single Treatment Days 8 - 19 QID Treatment Cohort 3: PP - 001 (0.30%) * - Key inclusion criteria:
Slide 14: OBG Crosslinked Hyaluronic Acid
14 OBG Crosslinked Hyaluronic Acid
Slide 15: Ocular Surface Diseases
15 Ocular Surface Diseases ~2 million US patients Injuries / abrasions Chemical burns Difficult to heal PED/ulcers 3% ~28 million US patients Contact lens wear Ocular irritants Glaucoma medications 53% ~5 million US patients Refractive surgeries (e.g., PRK) Cataracts Collagen cross - linking 9% Woun
Slide 16: Refractive Market Opportunity for Wound Healing
16 Refractive Market Opportunity for Wound Healing 1 American Academy of Ophthalmology and Ocular Surgery News: April 10, 2019 What Is PRK? • PRK is a surgical correction of refractive errors for patients who are not suitable candidates for LASIK due to: o Inadequate corneal thickness o Larger pupil
Slide 17: OBG, a Natural Substance Promoting Healing
17 • OBG is based on a modified form of the natural polymer hyaluronic acid (HA) • HA is a material with a high viscosity that promotes wound healing by enabling enhanced cell migration OBG, a Natural Substance Promoting Healing FDA Regulatory Note: OBG now classified as a drug, not a device
Slide 18: Covalent Crosslinking Creates Unique Attributes Ideal for Ocular Surface
18 Covalent Crosslinking Creates Unique Attributes Ideal for Ocular Surface • Improved Product Stability • Longer retention on the ocular surface over non - crosslinked HA (2 hours vs minutes) • Higher shear - thinning properties: – Able to achieve concentrations up to 7.5x current products (0.75% v
Slide 19: PRK Study Design
19 PRK Study Design ClinicalTrials.gov Identifier: NCT03938883 Enrolled patients undergoing PRK surgery (N=250) Day 0 PRK Surgery Week 2 Post - surgery Follow - up Measure differences in outcomes Screening (n=234) OBG (crosslinked HA eye drop) Standard - of - care (bandage contact lens) Randomize Da
Slide 20: OBG Demonstrated Superiority versus BCL
20 OBG Demonstrated Superiority versus BCL BCL: bandage contact lens BCL BCL 0% 20% 40% 60% 80% 100% OBG BCL Percent of Patients with Complete Re - Epithelialization Day 3 (Mean ± SEM) p < 0.01 RECURRENT EROSION Only 1 (0.9%) study eye in the OBG group had a recurrent erosion; there were 4 (3.5%) in
Slide 21: B-203 (BENAQ) Molecular Photoswitch
21 B - 203 (BENAQ) Molecular Photoswitch * * - Acquisition of Bayon Therapeutics pending, definitive agreement under negotiation
Slide 22: Retinitis Pigmentosa (RP) – Disease Overview
22 Retinitis Pigmentosa (RP) – Disease Overview American Academy of Ophthalmology Acquisition of Bayon Therapeutics pending, definitive agreement under negotiation ▪ 50+ genetically distinct subtypes from 150+ mutations ▪ Inherited disease Etiology ▪ Night blindness, reduced visual field range and e
Slide 23: RP – How Retinal Degeneration Occurs
23 RP – How Retinal Degeneration Occurs Acquisition of Bayon Therapeutics pending, definitive agreement under negotiation ▪ Normal human retina has about 120 million rods (black & white, night vision, movement) and 6 million cones (color) ▪ Photoreceptors die (rods first, then cones), unable to acti
Slide 24: B-203: Turns RGCs ON in the Presence of Light
24 B - 203: Turns RGCs “ON” in the Presence of Light Neuron. 92, 100 - 113 (2016) Acquisition of Bayon Therapeutics pending, definitive agreement under negotiation 1. In RP, photoreceptors are no longer viable and therefore their companion “signal” cells (RGCs) are not capable of being activated or
Slide 25: B-203: Flips Light Switch Response ON and OFF
25 B - 203: Flips Light Switch Response “ON” and “OFF” Sci. Rep. 7, 45487 (2017) Acquisition of Bayon Therapeutics pending, definitive agreement under negotiation Neural response to light B - 203 is selective for RGCs in Degenerating Retinas Normal Retina Diseased Retina
Slide 26: B-203: How Much and Which Wavelengths of Light is Needed?
26 10 13 10 14 10 15 10 16 10 17 0.0 0.2 0.4 0.6 Light Intensity (photons/cm 2sec) L i g h t R e s p o n s e I n d e x Moonlight 100w Incandescent Light Bulb Cloudy Day Sunlight Light Intensity (photons/cm 2 · sec) B - 203: How Much and Which Wavelengths of Light is Needed? Sci. Rep. 7, 45487 (2017)
Slide 27: B-203 – Behavioural Changes in Diseased Mice
27 B - 203 – Behavioural Changes in Diseased Mice Neuron. 81, 800 - 813 (2014). This study used a predecessor molecule that behaves similarly to BENAQ, but less potent and shorter in vivo half - life. rd1 mouse has an inherited gene mutation causing similar retinal degeneration as observed in RP pat
Slide 28: B-203: Phase 1b Study Design
28 B - 203 X µg B - 203 Y µg B - 203 Y µg B - 203 Z µg 3 Patients (NLP/LP) Contralateral eye of same pts Single IVT dosing (Y > X) Same schedule of activities 3 Patients (HM) Investigator led safety assessment along and between cohorts 3 Patients (NLP/LP) Cohort 1 Cohort 2 X < Y < Z Day 1 Day 2, 4,
Slide 29: Anticipated Milestones
29 Anticipated Milestones • PP - 001 – Topline POC Dry Eye data – Oral formulation complete • OBG – PIND for Ph3b readiness (PRK) • B - 203* – ODD Filing (RP) • PP - 001 – US IND filing Dry Eye • OBG – Topline POC data in persistent epithelial defect patients • B - 203* – FPI Ph1b RP Trial – PIND fo
Slide 30: Thank You
Sept 2021 THANK YOU
EyeGate Pharmaceuticals — Investor Presentation (September 2021) on 6ix